CancerEntMedPallNCT06648733
Improving Pharmacological Transition of Palliative Care Patients From Inpatient to Outpatient Care
A study testing Structured pharmaceutical discharge management in people with Cancer and Heart Failure, run by University Hospital Muenster at 1 site in Germany.
Trial summary
The transition of palliative care patients from inpatient to outpatient care is aimed to be improved through structured pharmaceutical discharge management by a trained pharmacist. This data will be compared with retrospective cases. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Cancer, Heart Failure, COPD
- What is being tested?
- Structured pharmaceutical discharge management
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 200 participants
- Where
- 1 siteGermany
- Study dates
- 20 Jun 2024to 31 Dec 2025
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- All individual indications for general and specialised palliative care as part of routine clinical practice (e.g.):
- advanced, malignant tumour disease
- advanced, chronic obstructive pulmonary disease
- Patients with advanced disease and limited life expectancy (approx. 12 months) Further care in the SOPC Muenster (prospective data) Sufficient understanding of the German language to be able to understand the information and consent form
Who cannot join
- Impossibility of understanding the information and declaration of consent.
Trial locations and contacts
1 site in 1 country.
Germany1 site, 1 recruiting
- Recruiting
University Hospital Muenster
Münster, North Rhine-Westphalia, 48149
Philipp Lenz, Prof. Dr. med., +49 (0)251 8353052, philipp.lenz@ukmuenster.de
Christoph Klaas, Dr. rer. nat.
About this study
Official title: Improving Pharmacological Transition of Palliative Care Patients From Inpatient to Outpatient Care (Optimierung Der Pharmakologischen Überleitung Von Palliativpatient:Innen Von stationär Nach Ambulant)
The transition of palliative care patients from inpatient to outpatient care is aimed to be improved through structured pharmaceutical discharge management by a trained pharmacist. This data will be compared with retrospective cases.
Read the detailed description
As part of a prospective observational study with a retrospective comparison group, a pharmacist should, on request, check the discharge medication planned by the primary care physicians before discharge and discuss it with the various colleagues providing (follow-up) care. In addition, the availability in the outpatient "medicine cabinet" and the possibility of prescribing by the responsible GPs (by telephone) should be checked in advance. In addition, longitudinal focus groups with relevant stakeholders are to be conducted to collect quantitative data as well as qualitative data on the views of those providing and receiving treatment.
There will be cooperation with the Specialized Outpatient Palliative Care Service Muenster to ensure sufficient case numbers and a low rate of missing values through partial use of the standard care data from the "Information System Palliative Care" (ISPC) program they use.
- Conditions
- Cancer, Heart Failure, COPD
- Being tested
- Structured pharmaceutical discharge management
- Keywords
- Palliative Care
- Medical subject headings
- Neoplasms, Heart Failure, Pulmonary Disease, Chronic Obstructive
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Structured pharmaceutical discharge managementOther
These patients will receive structured pharmaceutical discharge management from inpatient to outpatient care.
| Study group | Role | What they receive |
|---|---|---|
| Prospective patients | Experimental | Current palliative care patients who are discharged from the University Hospital to outpatient palliative care. Receives: Other: Structured pharmaceutical discharge management |
| Retrospective patients | No intervention | Former palliative care patients who were discharged from the university hospital to outpatient palliative care. |
What is being measured
The primary outcome is the main question the study is designed to answer.
(I) Drug-related problems
(I) Number of drug-related problems at the time of discharge according to PCNE (comparison of prospective, actually proposed changes vs. hypothetical number and type of problems at the time of discharge in the retrospective comparison cohort)
Measured: 12 months
(II) Drug-related problems
(II) Type of drug-related problems at the time of discharge according to PCNE (comparison of prospective, actually proposed changes vs. hypothetical number and type of problems at the time of discharge in the retrospective comparison cohort)
Measured: 12 months
Secondary outcomes (15)
Number of contacts
Number of contacts made by patients/relatives with SOPC within 7 days of discharge
Measured: 12 months
Number of readmissions / visits
Number of readmissions and / or visits to the emergency department within 7 and 14 days after hospital discharge
Measured: 12 months
Symptom burden
Change in patient symptom burden via Integrated Palliative Care Outcome. The total scores using the IPOS can range between 0 and 68 points. The higher the score, the more severe are the patient's symptoms. Scale after 3, 7 and 14 days compared to day 0 (discharge date)
Measured: 12 months
(I) Medication changes
(I) Number of medication changes suggested by pharmacists according to PCNE
Measured: 12 months
Adoption rate
Adoption rate by the primary care physicians of the pharmacist's proposed changes after PCNE (see primary endpoint)
Measured: 12 months
(I) GP contact
(I) Contact made with GPs for medication planning
Measured: 12 months
(I) SOPC contact
(I) Contact made with SOPC for medication planning and (II) resulting changes to discharge medication
Measured: 12 months
(I) Post-discharge medication changes
Change in the number of medications in outpatient follow-up care
Measured: 12 months
Focus groups
Satisfaction of inpatient physicians and those providing further treatment with forward-looking medication planning in 3 focus groups
Measured: 12 months
(I) Further parameters
(I)Evaluation of further quantitative parameters from ISPC (SOPC)
Measured: 12 months
(II) Medication changes
(II) Type of medication changes suggested by pharmacists according to PCNE
Measured: 12 months
(II) GP contact
(II) Resulting changes to discharge medication following GP contact
Measured: 12 months
(II) SOPC contact
(II) Resulting changes to discharge medication following SOPC contact
Measured: 12 months
(II) Post-discharge medication changes
(II) Qualitative assessment of medication changes (classification of drug-related problems according to PCNE)
Measured: 12 months
(II) Further parameters
(II) Evaluation of further quantitative parameters from the clinical information system (UKM)
Measured: 12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Oct 2024
- Study start20 Jun 2024
- Primary completion30 Jun 2025 (estimated)
- Study completion31 Dec 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for CancerStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Supportive care
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 200 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University Hospital Muenster
- Sponsor type
- University, hospital or other
- Collaborators
- University Hospital Munich
- Responsible party
- Sponsor
- Investigators
- Christoph Klaas, Dr. rer. nat., Study chair, Pharmacy of the University Hospital Muenster
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06648733
- Sponsor's protocol ID
- 2024-258-f-S
- Other IDs
- 2025-131-BO
- Acronym
- EntMedPall
- Status last verified
- Oct 2024
- First submitted
- 27 Jun 2024
- Last updated
- 13 Jun 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 13 Jun 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Improving Pharmacological Transition of Palliative Care Patients From Inpatient to Outpatient Care (Optimierung Der Pharmakologischen Überleitung Von Palliativpatient:Innen Von stationär Nach Ambulant)
- ClinicalTrials.gov ID
- NCT06648733
- Acronym / sponsor ID
- EntMedPall / 2024-258-f-S
- Conditions
- Cancer, Heart Failure, COPD
- Keywords
- Palliative Care
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 200 participants (estimated)
- Lead sponsor
- University Hospital MuensterUniversity, hospital or other
- Collaborators
- University Hospital Munich
- Study start
- 20 Jun 2024 (actual)
- Primary completion
- 30 Jun 2025 (estimated)
- Study completion
- 31 Dec 2025 (estimated)
- First posted
- 18 Oct 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The transition of palliative care patients from inpatient to outpatient care is aimed to be improved through structured pharmaceutical discharge management by a trained pharmacist. This data will be compared with retrospective cases.
Detailed description
As part of a prospective observational study with a retrospective comparison group, a pharmacist should, on request, check the discharge medication planned by the primary care physicians before discharge and discuss it with the various colleagues providing (follow-up) care. In addition, the availability in the outpatient "medicine cabinet" and the possibility of prescribing by the responsible GPs (by telephone) should be checked in advance. In addition, longitudinal focus groups with relevant stakeholders are to be conducted to collect quantitative data as well as qualitative data on the views of those providing and receiving treatment.
There will be cooperation with the Specialized Outpatient Palliative Care Service Muenster to ensure sufficient case numbers and a low rate of missing values through partial use of the standard care data from the "Information System Palliative Care" (ISPC) program they use.
Study design
- Primary purpose
- Supportive care
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Prospective patients | Experimental | Other: Structured pharmaceutical discharge managementCurrent palliative care patients who are discharged from the University Hospital to outpatient palliative care. |
| Retrospective patients | No intervention | –Former palliative care patients who were discharged from the university hospital to outpatient palliative care. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- All individual indications for general and specialised palliative care as part of routine clinical practice (e.g.):
- advanced, malignant tumour disease
- advanced, chronic obstructive pulmonary disease
- Patients with advanced disease and limited life expectancy (approx. 12 months) Further care in the SOPC Muenster (prospective data) Sufficient understanding of the German language to be able to understand the information and consent form
Key exclusion criteria (1 listed)
- Impossibility of understanding the information and declaration of consent.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Structured pharmaceutical discharge managementThese patients will receive structured pharmaceutical discharge management from inpatient to outpatient care. | Other | Prospective patients |
Primary outcome
(I) Drug-related problems
Time frame: 12 months
(I) Number of drug-related problems at the time of discharge according to PCNE (comparison of prospective, actually proposed changes vs. hypothetical number and type of problems at the time of discharge in the retrospective comparison cohort)
(II) Drug-related problems
Time frame: 12 months
(II) Type of drug-related problems at the time of discharge according to PCNE (comparison of prospective, actually proposed changes vs. hypothetical number and type of problems at the time of discharge in the retrospective comparison cohort)
15 secondary outcomes
Number of contacts
Time frame: 12 months
Number of readmissions / visits
Time frame: 12 months
Symptom burden
Time frame: 12 months
(I) Medication changes
Time frame: 12 months
Adoption rate
Time frame: 12 months
(I) GP contact
Time frame: 12 months
(I) SOPC contact
Time frame: 12 months
(I) Post-discharge medication changes
Time frame: 12 months
Focus groups
Time frame: 12 months
(I) Further parameters
Time frame: 12 months
(II) Medication changes
Time frame: 12 months
(II) GP contact
Time frame: 12 months
(II) SOPC contact
Time frame: 12 months
(II) Post-discharge medication changes
Time frame: 12 months
(II) Further parameters
Time frame: 12 months
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 13 Jun 2025.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Christoph Klaas, Dr. rer. nat. study chair
Pharmacy of the University Hospital Muenster
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Structured pharmaceutical discharge management in people with Cancer and Heart Failure, run by University Hospital Muenster at 1 site in Germany.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 13 Jun 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Germany. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Christoph Klaas, Dr. rer. nat. (+49 251 83-48843, christoph.klaas@ukmuenster.de), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
(I) Drug-related problems (time frame: 12 months). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 13 Jun 2025.